Hearing and Brain Development Cohort in Children and Adolescents

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT07625462
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Accepted

Study Details

This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.

Key Dates

First listed
Jun 4, 2026
Start date
May 20, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: HA
    Participants suitable for unilateral or bilateral hearing aid(s) fitting, without any other intervention methods (cochlear implantation, gene therapy treatment, auditory brainstem implantation, etc.).
  • Arm: CI
    Participants suitable for unilateral or bilateral cochlear implantation, without gene therapy treatment or auditory brainstem implantation.
  • Arm: ABI
    Participants suitable for unilateral or bilateral auditory brainstem implantation.
  • Arm: GT
    Participants suitable for gene therapy treatment.
  • Arm: FU
    Participants with hearing loss who do not receive any intervention.
  • Arm: NH Control
    Participants with normal hearing who are enrolled as healthy controls.

Primary Outcome Measure

Change in Categories of Auditory Performance-II Score [ Time Frame: From baseline to 24-month follow-up ]

Central Contacts

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